Evidence map›Paper›PMID 37349849›Full record

ArticleTrials2023

Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial.

Scott C Mackenzie, Jacqueline Stephen, Linda Williams, Jane Daniels, John Norrie, Christian M Becker, Dominic Byrne, Ying Cheong, T Justin Clark, Kevin G Cooper and 16 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. Improved Identification of Occult Peritoneal Endometriosis Using ABCt.JSLS : Journal of the Society of Laparoendoscopic Surgeons
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 15 institutions in 4 countries.

Scott C MackenzieMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.ORCID http://orcid.org/0000-0001-5823-4334
Jacqueline StephenEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE, Edinburgh BioQuarter, Edinburgh, EH16 4UX, UK.ORCID http://orcid.org/0000-0003-4997-3017
Linda WilliamsEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE, Edinburgh BioQuarter, Edinburgh, EH16 4UX, UK.ORCID http://orcid.org/0000-0002-6317-1718
Jane DanielsNottingham Clinical Trials Unit, University of Nottingham, Nottingham, NG7 2RD, UK.ORCID http://orcid.org/0000-0003-3324-6771
John NorrieEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, NINE, Edinburgh BioQuarter, Edinburgh, EH16 4UX, UK.ORCID http://orcid.org/0000-0001-9823-9252
Christian M BeckerEndometriosis CaRe, Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, OX3 9DU, UK.ORCID http://orcid.org/0000-0002-9870-9581
Dominic ByrneRoyal Cornwall Hospitals NHS Trust, Truro, UK.
Ying CheongFaculty of Medicine, Human Development and Health, University of Southampton, Southampton, UK.ORCID http://orcid.org/0000-0001-7687-4597
T Justin ClarkBirmingham Women's and Children Hospital, Birmingham, B15 2TG, UK.ORCID http://orcid.org/0000-0002-5943-1062
Kevin G CooperNHS Grampian, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN, UK.ORCID http://orcid.org/0000-0003-1486-0071
Emma CoxEndometriosis UK, London, UK.
Ann M DoustMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.ORCID http://orcid.org/0000-0001-8726-7186
Priscilla FernandezMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.
Jeremy HaweCorniche Hospital, Abu Dhabi, United Arab Emirates.
Tom HollandGuys and St Thomas NHS Trust, London, UK.ORCID http://orcid.org/0000-0001-5727-0659
Lone HummelshojEndometriosis.org, London, UK.ORCID http://orcid.org/0000-0003-1490-7802
Louise J JacksonUniversity of Birmingham, Birmingham, UK.ORCID http://orcid.org/0000-0001-8492-0020
Kathleen King, Letterkenny, Ireland.
Abha MaheshwariAberdeen Fertility Centre, NHS Grampian, Aberdeen, UK.ORCID http://orcid.org/0000-0002-3652-2447
Dan C MartinDepartment of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN, USA.
Lauren SutherlandMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.ORCID http://orcid.org/0000-0001-5465-8586
Jim ThorntonUniversity of Nottingham, Nottingham, UK.ORCID http://orcid.org/0000-0001-9764-6876
Katy VincentEndometriosis CaRe, Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, OX3 9DU, UK.ORCID http://orcid.org/0000-0001-9249-2492
Sanjay VyasSouthmead Hospital, North Bristol NHS Trust, Bristol, BS10 5NB, UK.
Andrew W HorneMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.ORCID http://orcid.org/0000-0002-9656-493X
Lucy H R WhitakerMRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK. lucy.whitaker@ed.ac.uk.ORCID http://orcid.org/0000-0002-7678-6551
MRC Centre for Reproductive Health · GBUniversity of Edinburgh · GBEndometriosis · GBUniversity of Nottingham · GBUniversity of Oxford · GBAberdeen Royal Infirmary · GBBirmingham Women's Hospital · GBCorniche Hospital · AELetterkenny Institute of Technology · IENHS Grampian · GBNorth Bristol NHS Trust · GBRoyal Cornwall Hospital Trust · GBUniversity of Birmingham · GBUniversity of Southampton · GBUniversity of Tennessee Health Science Center · US

Funding

Chief Scientist Office PCL/19/01Medical Research Council MR/N022556/1
6 · The paper itself

Abstract

backgroundEndometriosis affects 190 million women and those assigned female at birth worldwide. For some, it is associated with debilitating chronic pelvic pain. Diagnosis of endometriosis is often achieved through diagnostic laparoscopy. However, when isolated superficial peritoneal endometriosis (SPE), the most common endometriosis subtype, is identified during laparoscopy, limited evidence exists to support the common decision to surgically remove it via excision or ablation. Improved understanding of the impact of surgical removal of isolated SPE for the management of chronic pelvic pain in women is required. Here, we describe our protocol for a multi-centre trial to determine the effectiveness of surgical removal of isolated SPE for the management of endometriosis-associated pain.

methodsWe plan to undertake a multi-centre participant-blind parallel-group randomised controlled clinical and cost-effectiveness trial with internal pilot. We plan to randomise 400 participants from up to 70 National Health Service Hospitals in the UK. Participants with chronic pelvic pain awaiting diagnostic laparoscopy for suspected endometriosis will be consented by the clinical research team. If isolated SPE is identified at laparoscopy, and deep or ovarian endometriosis is not seen, participants will be randomised intraoperatively (1:1) to surgical removal (by excision or ablation or both, according to surgeons' preference) versus diagnostic laparoscopy alone. Randomisation with block-stratification will be used. Participants will be given a diagnosis but will not be informed of the procedure they received until 12 months post-randomisation, unless required. Post-operative medical treatment will be according to participants' preference. Participants will be asked to complete validated pain and quality of life questionnaires at 3, 6 and 12 months after randomisation. Our primary outcome is the pain domain of the Endometriosis Health Profile-30 (EHP-30), via a between randomised group comparison of adjusted means at 12 months. Assuming a standard deviation of 22 points around the pain score, 90% power, 5% significance and 20% missing data, 400 participants are required to be randomised to detect an 8-point pain score difference. DISCUSSION: This trial aims to provide high quality evidence of the clinical and cost-effectiveness of surgical removal of isolated SPE.

trial registrationISRCTN registry ISRCTN27244948. Registered 6 April 2021.

Indexed as

Chronic PainEndometriosisLaparoscopyFemaleHumansMulticenter Studies as TopicPelvic PainQuality of LifeRandomized Controlled Trials as TopicState MedicineEndometriosisLaparoscopyPelvic painRandomised controlled trialSurgical ablationSurgical excision

Identifiers

PMID37349849
PMCPMC10286505
OpenAlexW4381686958

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.